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KYLEENA (levonorgestrel), intrauterine device with progestin

GYNAECOLOGY - New medicinal product
Opinions on drugs - Posted on Oct 24 2018

Reason for request

Inclusion

High clinical benefit in contraception, though no demonstrated clinical benefit over MIRENA and JAYDESS.

  •  KYLEENA has been granted marketing authorisation in contraception, for a maximum period of 5 years.
  • During two open-label comparative studies, lasting 3 years, with no statistical analysis:

    - in one study, the observed Pearl index was 0.82 with KYLEENA and 0.00 with MIRENA

    - in the other study, the observed Pearl index was 0.31 with KYLEENA and 0.33 with JAYDESS. For patients included in an extension phase the PEARL index of KYLEENA was 0.29 [0.16; 0.50] over a 5-year contraception period.

  • At the end of the 3-year study period, the duration of bleeding per 90-day period was similar between the groups having received KYLEENA, MIRENA and JAYDESS. The proportion of patients with amenorrhoea after 3 years was similar for MIRENA and KYLEENA, and higher for KYLEENA than for JAYDESS.

  • As is the case of other intrauterine devices with progestin, this is a second-line contraceptive device, after copper devices. 

 

 


Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

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